The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for Respirgard Ii, Spirogard.
| Device ID | K961838 |
| 510k Number | K961838 |
| Device Name: | RESPIRGARD II, SPIROGARD |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Contact | Tom Dielmann |
| Correspondent | Tom Dielmann MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-13 |
| Decision Date | 1996-10-18 |